FDA MedWatch – Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL) by Eugia US

TOPIC: Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL) by Eugia US: Recall – Due to the Presence of Particulate Matter

AUDIENCE: Patient, Health Professional, Pharmacy, Infectious Disease

ISSUE: Eugia US is recalling lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial due to a product complaint for the presence of a dark red, brown and black particulate inside the vial.

It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023. Eugia US shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.

Risk Statement: The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening.

To date, Eugia US has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.

For more information about this recall click on the red button “Read Recall” below.

BACKGROUND: AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV- 1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients.

RECOMMENDATIONS: Eugia US is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled product.

• Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold and contact the company.
• Patients / consumers that have the product lot which is being recalled should contact the company or their physician as appropriate.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• General questions regarding the return of this product should be directed to the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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